Kornimate/medical-research-clean huggingface dataset:
cryospray therapy for benign airway stenosis

Conditions: Stenosis Trachea

Summary: this is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. the investigators hypothesize that the addition of sct to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.

spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of bcas and is used as part of routine clinical care by many physicians, but there is a relative paucity of peer-reviewed data, and no randomized controlled trial has been performed. thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.

Eligibility criteria:
inclusion criteria: * referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis. * significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest ct or previous bronchoscopy * able to provide informed consent. * age \> 18 exclusion criteria: * inability to provide informed consent * pregnancy * known or suspected malignant central airway stenosis * patient has already been enrolled in this study. * study subject has any disease or condition that interferes with safe completion of the study including: 1. hypoxemia with need for supplemental oxygen ≥ 2l/min by nasal canula 2. pneumothorax in the previous 12 months 3. severe copd (defined as a fev1/fvc \< 70% and fev1 \<30% predicted) and/or severe persistent asthma. 4. hemodynamic instability with systolic blood pressure \ 120 beats/min, unless deemed to be stable with these values by the attending physicians. 5. compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs. 6. significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. peg tube) 7. significantly reduced elasticity of the ablation area (e.g. marfan's syndrome) * prior complications with sct (spray cryotherapy) * contraindication to rigid bronchoscopy * significant tracheomalacia or alterations in cartilage integrity on ct (computed tomography) that would require stent placement or surgical referral. * greater than 1 bcas intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment. * anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from liquid nitrogen cannot adequately vent.

Keywords: cryospray therapy benign airway stenosis
application of medical imaging procedures in surgery implanting in cancerology with the aim to reduce invasive acts

Conditions: Upper Digestive Tract Cancer

Summary: aero digestive cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. the purpose of the study is to investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

* investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps * investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps) * investigate the delay of mucous healing * estimate the prosthetic function * evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation * estimate the implant rate due to minimally invasive flaps * estimate the implant rate due to pure trans mucosa way * estimate the post surgical therapeutic success after 1 year

Eligibility criteria:
inclusion criteria: * age over 18 * performance status over 70 * histological evidence of upper digestive tract cancer * history of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer. * bone volume sufficient to support an implant. * mandatory affiliation with a social security system * written, voluntary, informed consent exclusion criteria: * patient with evolutive malignant disease * contraindication to general anesthesia * concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, hiv, evolutive neoplasia...) * patient enrolled in another clinical trial including chemotherapy * pregnant or lactating woman * anticipation of an impossible follow-up * patient deprived of freedom

Keywords: upper digestive tract cancer implants implants insertion radio-surgical guidance accuracy of implants insertion cranial/facial radiotherapy or brachytherapy and/or microvascular fibula transfer. bone volume sufficient to support an implant
tamoxifen citrate in patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can promote growth of endocrine sensitive breast cancer cells. endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. pharmacokinetics and -genomics can have an impact on the efficacy of the treatment. purpose: this phase iii trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.

objectives: primary * to determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer. secondary * to characterize the population pharmacokinetic profile * to investigate the role of the other cyps * to assess the relation between clinical symptoms and cyp2d6 genotypes and/or active metabolites levels * to explore the correlation between genotypes/metabolites levels and clinical outcomes in terms of tumor relapse. * to assess the feasibility, efficacy, and safety of concentration-guided adjustment of tamoxifen citrate dosage. * to conduct other exploratory analysis based on the eventual new data coming up in the future. outline: patients receive oral tamoxifen citrate (at a dose of 40 mg/day) daily for 4 months in the absence of disease progression or unacceptable toxicity. blood samples are collected for pk, genotyping, phenotyping, and further analysis.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * hormone-sensitive breast cancer defined as \> 10% estrogen receptor and/or \> 10% progesterone receptor positivity by immunohistochemistry * receiving treatment with tamoxifen citrate and must be eligible for exposure to higher doses patient characteristics: * no history of deep venous thrombosis or pulmonary embolism * no history of endometrial carcinoma * no known history of vaginal bleeding, endometriosis, endometrial hyperplasia, endometrial hypertrophy, and/or polyps * not pregnant or nursing * no contraindication to tamoxifen citrate treatment * no known allergy to midazolam or dextromethorphan prior concurrent therapy: * see disease characteristics

Keywords: endocrine sensitive breast cancer tamoxifen genotyping phenotyping pharmacokinetics endoxifen
abdominal aortic aneurysm screening before coronary artery bypass surgery

Conditions: Coronary Artery Disease; Abdominal Aortic Aneurysm

Summary: coronary artery disease (cad) and abdominal aortic aneurysm (aaa) are two separate entities with common risk factors such as hypertension, advanced age, male sex. atherosclerosis plays an important role in the etiology of both diseases. it has been reported that aaa is more prevalent in patients undergoing coronary artery bypass grafting (cabg). despite all the evidence, current guidelines do not recommend routine screening for aaa before cabg. syntax score shows anatomical significance of cad and is associated with the degree of atherosclerotic load. the investigators aim to investigate if there were any differences regarding aaa prevalence in high-syntax patients versus intermediate/low-syntax patients.


Eligibility criteria:
inclusion criteria: * undergoing coronary artery bypass graft surgery * age \>18 years exclusion criteria: * age \<18 years * pregnancy * breastfeeding * emergency surgery
long-term effects reset your mind - mechanisms

Conditions: Depression Mild; Depression Moderate

Summary: see: clinicaltrials.gov id: nct05402150 relevant for this paper: this investigation aims to evaluate the stability of the effectiveness of different two-week online interventions in a four months follow-up regarding reward sensitivity, anhedonia and depression. the authors will further investigate factors influencing treatment success regarding reward sensitivity. the investigators assume that the more depressive expectations and stress improve during our online intervention, the more change in reward insensitivity is experienced at follow-up. in addition, it is hypothesized that the more people engaged in physical activities and social encounters during the two-week online intervention, the more change in reward insensitivity is experienced at follow-up.

see for main study: clinicaltrials.gov id: nct05402150. a possible maintaining role in depressive symptoms plays reward hyposensitivity. therefore, treatments should include evidence-based psychological interventions that target and modify reward insensitivity. prior research lacks studies investigating reward sensitivity as main outcome measure, especially in the web-based format. this is why this study investigated an online intervention with the following groups regarding effectively increasing reward sensitivity compared to a waitlist control condition: a) mindfulness-based interventions, b) behavioral activation, c) a combination of both. the daily exercises were supported via videos and worksheets. here, the investigators explore the effects after a four-months follow-up. in addition, this paper will deal with the long-term prediction of reward sensitivity, a feature not considered in our main paper preregistered with the id nct05402150. factors, which are considered to play a big role in reward sensitivity are perceived stress, depressive expectations, physical activity and the frequency of social encounters.

Eligibility criteria:
inclusion criteria: * age 18 or above * fluent in german * informed consent * depressive symptoms (phq-9 \> 5) exclusion criteria: * suicidality, severe depression * current or lifetime: substance use disorder, psychotic disorders, bipolar i or ii * current psychotherapy * if antidepressant medication: has not been stable over the last 4 weeks

Keywords: reward sensitivity reward processing depression randomized controlled trial online intervention behavioral activation mindfulness gratitude
crossover bioequivalence study of cevimeline 30 mg capsules under fed conditions

Conditions: Dry Mouth

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' cevimeline 30 mg under fed conditions


Eligibility criteria:
inclusion criteria: - no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to cevimeline or any comparable or similar product.
evaluation of various doses of ro 27-2771 (test drug) in asthmatic patients not treated with inhaled corticosteroids

Conditions: Asthma

Summary: the purpose of this study is to determine the appropriate dose of ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. the research is being conducted at up to 80 clinical research sites in the us, mexico, and canada. study participants will have a number of visits to a research site over approximately a 4-month period.


Eligibility criteria:
inclusion criteria: * persistent asthma for more than one year * current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only * in good health ad demonstrated by medical history and physical exam * negative urine pregnancy test * commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy exclusion criteria: * asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study * history of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year * undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study * history of chronic pulmonary diseases other than asthma * treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study * current tobacco use * smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked) * history or evidence of drug or alcohol abuse * diagnosis or evidence of an infectious illness within one month of visit 1 * clinically significant diseases as assessed by the study doctor * participation in another clinical study with an experimental drug within one month of start of the study
comparison of pnf and task related techniques along with tens on upper limb function among stroke patients

Conditions: Stroke

Summary: comparison of pnf and task related techniques along with tens on upper limb function among stroke patients

the objective of this study is to determine the comparison of pnf and trt along with tens on upper limb function recovery among stroke patients.

Eligibility criteria:
inclusion criteria: * duration of illness before participation in the study ranged from six to eighteen months' post stroke. * patients who diagnosed with ischemic stroke stage 2 and 3 * patients' age ranged from 50-70 years (male/female) * patients with sufficient cognitive abilities that enables them to understand and follow instructions (mini mental scale) exclusion criteria: * patients with communication problems * patients with a history of previous stroke or other neurological diseases or disorders * patients with inflammation, old fracture or prosthesis in the affected limb, neurological diseases that affect upper limb function other than stroke (e.g.: multiple sclerosis, peripheral neuropathy, parkinsonism .... etc.), infection or dermatological conditions on acupuncture sites, musculoskeletal disorders such as severe arthritis, cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, arrhythmia, implanted pacemaker or unstable hypertension) or pulmonary disorders, visual and auditory problems and patients with cognitive impairment. * any contra indications for tens, other neurological \& orthopedic conditions affecting upper limb, patient with subluxed shoulder, patient with shoulder hand syndrome.
a phase 1/2, randomized, placebo-controlled, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine in healthy adults 18 to 49 years of age

Conditions: Group B Streptococcal Infections

Summary: this is the phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group b streptococcus vaccine. healthy adults aged 18 to 49 years of age with no history of group b streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group b streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).


Eligibility criteria:
inclusion criteria: 1. healthy adults (male and female) 18 to 49 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. 2. negative urine pregnancy test at visit 1 for all female subjects who are of childbearing potential. exclusion criteria: 1. male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product. 2. acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. chronic medical conditions include human immunodeficiency virus, chronic hepatitis b virus (hbv) infection (hbv surface antigen positive), and/or hepatitis c virus infection. 3. history of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine. 4. history of microbiologically proven invasive disease caused by group b streptococcus (streptococcus agalactiae). 5. previous vaccination with any licensed or investigational group b streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).
ecg belt to assess electrical synchronization

Conditions: Bradycardia; Heart Failure

Summary: the objective of the study is to assess the utility of ecg belt to understand the conduction and ecg characteristics of left bundle branch pacing (lbbap) and his-optimized cardiac resynchronization therapy (hot-crt) and compare with preexisting data in traditional cardiac resynchronization therapy (crt) and right ventricular pacing (rvp).

the objective of the study is to assess the utility of ecg belt to understand the conduction and ecg characteristics of lbbp and hot-crt and compare with preexisting data in traditional crt and rvp. specific objective: * to demonstrate and establish electrical resynchronization using ecg belt research system in left bundle branch pacing (lbbp) and hot-crt. * to assess ecg belt derived native conduction parameters and compare them to lbbp and hot-crt. * to compare with historic ecg belt parameters obtained for right ventricular pacing/ biventricular pacing in prior studies. the ecg belt study is a prospective, single-center, investigational, pre-market research study. the study team will identify all patients who satisfy the inclusion and exclusion criteria. the study team will evaluate the ecg belt research system to assess the electrical characteristics of conduction system pacing in patients with preexisting lbbp or hot-crt. eligible patients would have successfully undergone lbbp using medtronic 3830 lead. lbbp will be confirmed at implant using left bundle potentials recorded from the lead, ecg morphology during unipolar and bipolar pacing, peak lv activation time and lead depth in the lv septum by contrast at implant and 2d echo post-implant. ecg belt would be used to record ecg during baseline rhythm, lbbp in unipolar and bipolar configurations and / or during hot-crt using his-bundle pacing (hbp) or lbbp. these ecg belt characteristics would then be compared with baseline and existing data on right ventricular rv pacing and traditional biventricular pacing.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age 2. patient has a previously implanted lbbp lead for bradycardia indication or heart failure indication with one of the following at geisinger within the last 5 years: * lbbp * lbbp+lv lead * hbp+lv 3. patient is willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: 1. inability to provide informed consent 2. pregnant 3. enrolled in a concurrent study that may confound the results of this study.
cymbopogon citratus gel as local drug delivery agent in reducing matrix metalloproteinase-8 levels intra-crevicularly in the treatment of stage ii periodontitis

Conditions: Periodontitis Chronic Generalized Moderate

Summary: background: phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (srp) to modulate inflammatory host response and eradicate microbes. matrix metalloproteinase-8 (mmp-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. since mmp-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of cymbopogon citratus (lemongrass oil) gel and biochemically on mmp-8 levels in gingival crevicular fluid (gcf) of stage ii periodontitis patients. methods: a randomized controlled clinical trial was conducted on forty patients with stage ii periodontitis, divided equally into two groups. group-i (test) was managed by srp with intra-pocket application of 2% lemongrass oil gel. group-ii (control) was managed by srp with intra-pocket application of a placebo gel. periodontal pocket depth (ppd) and clinical attachment loss (cal) were measured for both groups, before treatment and twelve weeks after. moreover, gcf was collected from both groups at baseline, one week, and twelve weeks after treatment. then analysed by enzyme-linked assay (elisa) technique.


Eligibility criteria:
inclusion criteria: * systemically healthy individuals of both sexes having moderate periodontitis (stage ii), cal 3-4mm, with an age ranging from 25 to 45 years old. * patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months exclusion criteria: * history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade c category that has rapid rate of progression, and pregnant or lactating women